Manufacturing Engineer III
3 weeks ago
Responsibilities: Generation and execution of validation plans, validation protocols (IQ/OQ/PQ), and completion reports, with a major focus on sterilization and microbiology of medical devices. Provide statistical analysis of the date to support the reports. Generation and implementation of change controls and engineering notices (ECO). Develop statistically based sampling plans for in-process and final testing and inspections, and validations. Troubleshooting equipment/processes that do not perform as intended during validation runs. Recommend process/quality improvements as part of validation runs. Evaluate, investigate and document non-conformances incidents and/or protocol deviations. Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports. Develops and maintains an effective cross-functional working relationship with plant and corporate Manufacturing, Engineering, Regulatory, and Quality Assurance personnel. Work on project teams with other internal departments, external vendors, and customers as required. ssure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others. Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions. Participate in external audits such as: FDA, Notified Body (BSI) and Corporate, among others. Performs other related duties as necessary. Requirements: BS in Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical (Professional Engineer License.) or sciences related field. Lean/Six Sigma Green or Black Belt Certification is a plus.Manufacturing equipment, manufacturing processes, stability or aging, required. Minimum of 4-6 years of experience in the medical device and/or pharmaceutical manufacturing environment. Knowledge in Organizational Excellence and Lean/Six Sigma. Strong Project Management skills. bility to lead teams through complex projects and provide departmental technical leadership. Must have excellent communication skills and a strong track record of working cross-functionally. Must have demonstrated ability to think strategically.
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Principal Manufacturing Engineer
2 months ago
Boston, Massachusetts, United States Michael Page Full timeGreat opportunity to make an immediate impact on people's livesJoin a mission driven start-up with high performing employees About Our Client My client is a pioneering leader in the medical equipment industry, committed to delivering innovative solutions that enhance patient care and safety. They are committed to providing innovative technologies with the...
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Manufacturing Engineer III
3 months ago
South Saint Paul, United States Renewal by Andersen Full timeDescription & Requirements RENEWAL BY...
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Manufacturing Engineer II/III
3 months ago
South Saint Paul, United States Renewal by Andersen Full timeDescription & Requirements RENEWAL BY...
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Manufacturing Engineer
1 month ago
Boston, United States Motion Recruitment Full timeOur client is at the forefront of innovation in the biotech and medical device industry. Their mission is to develop cutting-edge solutions that improve patient outcomes and revolutionize healthcare. They're seeking a talented and driven Manufacturing Engineer to join their dynamic team! As a Manufacturing Engineer on the team, you will posses a passion...
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Manufacturing Engineer
1 month ago
Boston, Massachusetts, United States Motion Recruitment Full timeOur client is at the forefront of innovation in the biotech and medical device industry. Their mission is to develop cutting-edge solutions that improve patient outcomes and revolutionize healthcare. They're seeking a talented and driven Manufacturing Engineer to join their dynamic teamAs a Manufacturing Engineer on the team, you will posses a passion for...
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Mechanical Engineer III
4 days ago
Boston, Massachusetts, United States CRB Full timeJob SummaryThe Mechanical Engineer III is a key member of our team, responsible for overseeing the mechanical discipline and managing the discipline budget on small to medium projects of limited complexity. This role requires strong leadership and coordination skills, as well as the ability to manage multiple complex tasks and direct the work of others.Key...
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Senior Manufacturing Engineer
3 weeks ago
Boston, United States DSJ Global Full timeSenior Manufacturing EngineerWe are seeking an individual to establish and maintain a new manufacturing process line using cutting-edge technology, including automation, 3-D printing, and robotics. The goal is to identify and implement improvement opportunities, applying lean manufacturing methodologies to ensure simpler, faster, cost-effective, and reliable...
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Senior Manufacturing Engineer
3 weeks ago
Boston, United States DSJ Global Full timeSenior Manufacturing Engineer We are seeking an individual to establish and maintain a new manufacturing process line using cutting-edge technology, including automation, 3-D printing, and robotics. The goal is to identify and implement improvement opportunities, applying lean manufacturing methodologies to ensure simpler, faster, cost-effective, and...
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Senior Manufacturing Engineer
2 weeks ago
Boston, Massachusetts, United States BRIOHEALTH SOLUTIONS INC Full timeJob OverviewAs a key member of the Operations team at BRIOHEALTH SOLUTIONS INC, you will play a vital role in the transition of products from research and development to full-scale manufacturing. Your expertise will ensure that products are designed for manufacturability and that processes are optimized for efficiency and quality.Key ResponsibilitiesDesign...
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Advanced Manufacturing Engineer
2 days ago
Boston, Massachusetts, United States BRIOHEALTH SOLUTIONS INC Full timeJob Description**About the Role**We are seeking a highly skilled Advanced Manufacturing Engineer to join our team at BRIOHEALTH SOLUTIONS INC. As a key member of our Operations team, you will work closely with cross-functional teams to design, develop, and implement manufacturing processes that meet our business needs.Key ResponsibilitiesDesign...
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Advanced Manufacturing Engineer
2 days ago
Boston, Massachusetts, United States BRIOHEALTH SOLUTIONS INC Full timeJob Description**About the Role**We are seeking a highly skilled Advanced Manufacturing Engineer to join our team at BRIOHEALTH SOLUTIONS INC. As a key member of our Operations team, you will work closely with cross-functional teams to design, develop, and implement manufacturing processes that meet our business needs.Key ResponsibilitiesDesign...
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Senior Manufacturing Engineer
2 weeks ago
Boston, Massachusetts, United States BRIOHEALTH SOLUTIONS INC Full timeJob OverviewAs a key member of the Operations team at BRIOHEALTH SOLUTIONS INC, you will play a crucial role in the successful transition of products from design to manufacturing. Your expertise will be essential in ensuring that new products, modifications, and enhancements are efficiently integrated into production.Key ResponsibilitiesDesign...
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Senior Manufacturing Engineer
3 days ago
Boston, United States Engtal Full timeAbout Us:Join a leading medical device company focused on innovation and improving patient outcomes. We are seeking a Senior Manufacturing Engineer to optimize processes and ensure high-quality production standards.Key Responsibilities:Lead process development and improvement for medical device products.Collaborate with R&D to ensure manufacturability (DFM)...
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Senior Manufacturing Engineer
7 days ago
Boston, Massachusetts, United States BRIOHEALTH SOLUTIONS INC Full timeJob OverviewAs a pivotal member of the Operations team at BRIOHEALTH SOLUTIONS INC, you will engage in a variety of critical tasks aimed at ensuring seamless product transitions from development to manufacturing.Key ResponsibilitiesDesign Transfer:Collaborate with R&D, Manufacturing Engineering, and Quality teams to facilitate the transition of products into...
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Manufacturing Engineer
1 month ago
New Boston, United States Masis Professional Group Full timeJob Purpose:Exciting career opportunity is available at a rapidly growing medical device contract manufacturer, for a Sr. Manufacturing Engineer. The purpose of this role is to provide Engineering support to daily production activities for medical device manufacturing. The position requires an expertise in medical device manufacturing applications including...
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Manufacturing Engineer
3 weeks ago
New Boston, United States Masis Professional Group Full timeJob Purpose:Exciting career opportunity is available at a rapidly growing medical device contract manufacturer, for a Sr. Manufacturing Engineer. The purpose of this role is to provide Engineering support to daily production activities for medical device manufacturing. The position requires an expertise in medical device manufacturing applications including...
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Advanced Manufacturing Engineer
4 weeks ago
Boston, United States BRIOHEALTH SOLUTIONS INC Full time $75,000 - $90,000Job DescriptionJob DescriptionDesign Transfer:As a member of the Operations team, you will work closely with R&D, Manufacturing Engineering and Quality to transfer products to manufacturing.You will develop and implement manufacturing plans to accomplish a robust design transfer from initial concept to full production to support new products, product changes...
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Advanced Manufacturing Engineer
3 months ago
Boston, United States BRIOHEALTH SOLUTIONS INC Full timeJob DescriptionJob DescriptionBrioHealth Solutions Inc., Inc. is seeking an experienced and driven Advanced Manufacturing Engineer to join our dynamic team. As an Advanced Manufacturing Engineer, you will play a pivotal role in the transfer of products and process technologies from R&D to Manufacturing ensuring safety, quality, and regulatory goals are...
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Senior Manufacturing Engineer
3 days ago
Boston, United States Engtal Full timeKey Responsibilities:Lead the design, implementation, and optimization of manufacturing processes for robotics and semiconductor products.Collaborate with R&D, production, and quality teams to ensure seamless transfer of new products into full-scale manufacturing.Identify, evaluate, and implement automation and process improvements to enhance production...
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Senior Manufacturing Engineer
1 day ago
Boston, United States Engtal Inc Full timeKey Responsibilities: Lead the design, implementation, and optimization of manufacturing processes for robotics and semiconductor products. Collaborate with R&D, production, and quality teams to ensure seamless transfer of new products into full-scale manufacturing. Identify, evaluate, and implement automation and process improvements to enhance production...